Sex-Based Disparities in the Electrophysiological Substrate for Atrial Fibrillation and Its Impact on Clinical Outcomes

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation (AF)

In brief

DISPARITY-AF is a prospective, single-center, observational registry designed to characterize the sex-based disparities in the electrophysiological substrate driving Atrial Fibrillation (AF). While standard Pulmonary Vein Isolation (PVI) is the cornerstone of AF ablation, women consistently experience lower long-term success rates. This study tests the hypothesis that women harbor a significantly higher burden of unmapped, extra-pulmonary vein (extra-PV) AF initiation sites compared to men. In 100 consecutive patients undergoing first-time PVI, comprehensive biatrial repolarization mapping will be performed using programmed electrical stimulation (PES) to measure the atrial effective refractory period (AERP) in multiple atrial sites immediately after successful PVI. All mapping systems and multielectrode catheters utilized in this study are clinically approved and used routinely in our center. Identified steep repolarization gradients (SRGs) and AF initiation sites will be documented but not ablated. Patients will undergo intensive 1-year clinical follow-up to test the secondary hypothesis that patients with untreated extra-PV SRG/AF initiation sites have a significantly higher rate of AF recurrence.

Key facts

Study ID

NCT07580547

Run by

Anat Milman

People needed

100

Starts

2026-05-05

Expected to finish

2028-04-19

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 18 and 80 years.
• Male or Female sex.
• Symptomatic paroxysmal or persistent AF indicated for a first-time catheter ablation.
• Ability to provide written informed consent.

You may not qualify if…

• Prior catheter ablation for AF or surgical MAZE.
• Long-standing persistent AF (>12 months).
• Presence of intracardiac thrombus or contraindication to systemic anticoagulation.
• Pregnant women and patients not able to provide an informed consent

Where it is running

• Shamir Medical Center — Be’er Ya‘aqov, Israel (enrolling)

Full record on ClinicalTrials.gov

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